Trial Outcomes & Findings for Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women (NCT NCT02858037)
NCT ID: NCT02858037
Last Updated: 2022-10-25
Results Overview
Number of participants Grade 2, Grade 3, and all serious Adverse Events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1456 participants
Primary outcome timeframe
13 months
Results posted on
2022-10-25
Participant Flow
MTN-025 was implemented as a follow-on trial to MTN-020, and the inclusion and exclusion criteria were used to ensure the appropriate selection of trial participants for MTN-025. The Decliner Population were former MTN-020 participants who declined participation in the main MTN-025 trial, and who met the inclusion and exclusion criteria Women in the Decliner Population were invited to complete a single visit which consisted of behavioral assessments.
Participants were recruited from RC cohorts of MTN-020 participants. Efforts were made by RCs to maintain contact with MTN-020 (ASPIRE) participants between the end of follow-up in MTN-020 and the initiation of the MTN-025 trial (HOPE) to provide MTN-020 trial results and information regarding the HOPE trial to participants.
Participant milestones
| Measure |
HIV Open-label Prevention
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Overall Study
STARTED
|
1456
|
|
Overall Study
Exposed Primary Cohort
|
1368
|
|
Overall Study
COMPLETED
|
1404
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
HIV Open-label Prevention
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Participant Relocated, no follow-up planned
|
26
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
Baseline characteristics by cohort
| Measure |
HIV Open-label Prevention
n=1456 Participants
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020:NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Age, Continuous
|
32.0 Years
STANDARD_DEVIATION 6.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1456 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1276 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
84 Participants
n=5 Participants
|
|
Region of Enrollment
Malawi
|
157 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
705 participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
172 participants
n=5 Participants
|
|
Region of Enrollment
Zimbabwe
|
422 participants
n=5 Participants
|
|
Marital Status
Not Married
|
770 Participants
n=5 Participants
|
|
Marital Status
Married
|
686 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 monthsPopulation: Exposed Primary Cohort - included all participants enrolled in the Main Trial Population
Number of participants Grade 2, Grade 3, and all serious Adverse Events.
Outcome measures
| Measure |
HIV Open-label Prevention
n=1368 Participants
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
At least one Grade 3 or higher AE
|
52 Participants
|
|
The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
At least one serious AE
|
19 Participants
|
|
The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
At least one grade 2 or higher related AE
|
2 Participants
|
PRIMARY outcome
Timeframe: 13 monthsPopulation: Exposed Human Immunodeficiency Virus Incidence and Adherence Cohort
By measuring the residual levels of dapivirine in returned used vaginal rings.
Outcome measures
| Measure |
HIV Open-label Prevention
n=1365 Participants
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Enrollment
|
21.0 mg
Interval 17.7 to 25.9
|
|
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Month 1
|
21.1 mg
Interval 17.0 to 26.3
|
|
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Month 2
|
21.0 mg
Interval 16.5 to 27.1
|
|
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Month 3
|
21.1 mg
Interval 16.4 to 27.8
|
|
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Month 6
|
21.2 mg
Interval 16.6 to 27.3
|
|
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Month 9
|
21.3 mg
Interval 15.8 to 27.1
|
SECONDARY outcome
Timeframe: 13 monthsPopulation: Exposed Human Immunodeficiency Virus Incidence and Adherence Cohort
HIV-1 infection as measured by the protocol algorithm
Outcome measures
| Measure |
HIV Open-label Prevention
n=1365 Participants
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Incidence of HIV-1 Infection
|
2.7 events per 100 person-years
|
SECONDARY outcome
Timeframe: 13 monthsPopulation: Virology Population - included all HIV-1 infected participants in the Exposed HIV Incidence and Adherence Cohort.
HIV-1 drug resistance mutations among participants who acquire HIV-1, as measured by standard genotype analysis and more sensitive methods to detect low frequency drug-resistant variants
Outcome measures
| Measure |
HIV Open-label Prevention
n=33 Participants
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.
|
6 Participants
|
Adverse Events
HIV Open-label Prevention
Serious events: 19 serious events
Other events: 844 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HIV Open-label Prevention
n=1368 participants at risk
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Gastrointestinal disorders
Gastrtitis
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Pneummonia
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Respiratory Track Infection
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Subcutaneous abscess
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Injury, poisoning and procedural complications
Contusion
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Injury, poisoning and procedural complications
Head injury
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Nervous system disorders
Headache
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Nervous system disorders
Optic neuritis
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Psychiatric disorders
Psychotic disorder
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Renal and urinary disorders
Acute kidney injury
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Reproductive system and breast disorders
Endometriosis
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Vascular disorders
Hypertension
|
0.07%
1/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
Other adverse events
| Measure |
HIV Open-label Prevention
n=1368 participants at risk
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020: NCT01617096 MTN-025: NCT02858037
Dapivirine Vaginal Ring: Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
|
|---|---|
|
Infections and infestations
Bacteria vaginosis
|
5.1%
70/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Genitourinary chlamydia infection
|
8.4%
115/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
4.2%
58/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Malaria
|
2.0%
28/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
67/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Urinary Tract Infection
|
5.2%
71/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
4.8%
65/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
5.9%
81/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Investigations
ALT increased
|
2.5%
34/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Investigations
AST increased
|
2.0%
28/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.6%
36/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
45/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Reproductive system and breast disorders
Vaginal discharge
|
8.0%
110/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.9%
54/1368 • 13 months
Treatment-emergent Adverse Events in ≥ 2.0% of Overall Participants by System Organ Class and Preferred Term, Regardless of Severity and Causality - Exposed Primary Cohort
|
Additional Information
Dr John Steytler
International Partnership for Microbicides
Phone: +27 21 860 2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER